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African American Depression Intervention Trial (AADI) (AADI)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Coping with Depression Course (CWD) and Oh Happy Day Class (OHDC)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria. Self-identified African-American men and women, between the ages of 30 to 60, with symptoms of depression as evidenced by data from the Composite International Diagnostic Interview 2.1 (CIDI). Although age of inclusion is broad, our pilot studies have shown positive outcomes with mixed aged groups

Exclusion Criteria:

  • Exclusion criteria. Individuals will be excluded from the study if they have: (1) self-reported alcohol or other drug abuse/dependence, (2) major psychotic illnesses, such as schizophrenia as evidenced by results of the CIDI, (3) self-reported changes in antidepressants (dosage or type) less than 6 weeks prior to participating in the study, (4) self-report of current psychotherapy treatment, or (5) self-report of current suicidal ideations (our psychiatrist will conduct additional suicide risk assessment and facilitate referral for appropriate care.

Sites / Locations

  • Mental Health Center of Dane County
  • Milwaukee Health Services, INC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lifestyle counseling (OHDC)

lifestyle counseling (CWD)

Arm Description

Oh Happy Day Class (OHDC) is a culturally-specific, 12-week cognitive behavioral group counseling intervention designed for African American adults experiencing depression

Coping with Depression Course (CWD) is a 8-week cognitive behavioral group counseling depression intervention

Outcomes

Primary Outcome Measures

Center for Epidemiologic Studies Depression Scale (CES-D)
Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D scale is a 20-item self-report inventory developed by NIMH to assess the frequency and severity of depression symptoms in the past week. Respondents indicate how often each symptom was experienced during the past week on a four-point scale from "Rarely or none of the time (0)", "Some or a little of the time (1)", "Occasionally or a moderate amount of the time (2)", or "Most or all of the time (3)". Item scores are summed for analyses, with a possible range 0-60. A standard cutoff score of 16 indicates depressive symptoms.

Secondary Outcome Measures

Quick Inventory of Depressive Symptomatology (QIDS)
The 16-item Quick Inventory of Depressive Symptomatology (QIDS) using DSM-IV criteria assesses depressive symptom severity and symptom change. The QIDS has a clinician-rated and self-report format. Studies show high internal consistency for the QIDS-CR (0.85) and QIDS-SR(0.86). Scores range from 0-27 and higher scores suggest higher severity. The QIDS also has high concurrent validity with the SF-12.

Full Information

First Posted
April 25, 2011
Last Updated
May 6, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01342536
Brief Title
African American Depression Intervention Trial (AADI)
Acronym
AADI
Official Title
A Culturally Adapted Depression Intervention for African American Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 14, 2011 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Aim 1: Examine effectiveness of the Oh Happy Day Class (OHDC) compared to the Coping With Depression (CWD)in increasing retention, adherence, engagement, satisfaction, and treatment-seeking. The investigators hypothesize the OHDC compared to the CWD will result in greater increases in: 1a. retention, 1b. adherence, 1c. engagement, and 1d. satisfaction at the middle and end of the intervention, and 2.e. greater increase in treatment-seeking 3-, 6-, 9-, and 12- months post-intervention. Outcome measures: logs: attendance, homework completion, class-participation level; Client Satisfaction Inventory; and Cornell Service Index. Primary Aim 2: Examine effectiveness of the OHDC in reducing symptoms of depression at the middle and immediate end of the intervention, and 3-, 6-, 9-, and 12- months post-intervention. The investigators hypothesize the OHDC will result in greater reduction in depressive symptoms compared to the CWD at 3-months post-intervention. Outcome measures: Center for Epidemiologic Studies Depression Scale and Quick Inventory of Depression Symptoms. Secondary Aim 3: Examine the effectiveness of the OHDC in improving self-reports of mental and physical health status and reducing self-reports of perceived disability. The investigators hypothesize the OHDC compared to the CWD will result in greater self-report of: 3a. improved mental and physical health status, and 3b. reduced self-report of disability at the immediate end of the intervention and 3-,6-, 9-, 12- months post-intervention. Outcome measures: SF-12 Health Survey, and World Health Organization Disability Assessment Schedule. Public Health Impact: Based on CAI research, the OHDC has the potential to be four times more effective than the CWD. If our hypotheses are proven, the OHDC will be the first evidence-based culturally adapted depression intervention designed specifically for African American men and women between the ages of 30-60.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lifestyle counseling (OHDC)
Arm Type
Experimental
Arm Description
Oh Happy Day Class (OHDC) is a culturally-specific, 12-week cognitive behavioral group counseling intervention designed for African American adults experiencing depression
Arm Title
lifestyle counseling (CWD)
Arm Type
Active Comparator
Arm Description
Coping with Depression Course (CWD) is a 8-week cognitive behavioral group counseling depression intervention
Intervention Type
Behavioral
Intervention Name(s)
Coping with Depression Course (CWD) and Oh Happy Day Class (OHDC)
Intervention Description
The OHDC is a culturally adapted, cognitive behavioral group counseling intervention. The OHDC is theoretically grounded in social learning theory and an Afrocentric paradigm (Nguzo Saba). It uses a social support group and psychoeducation format so participants learn skills to help them in coping and reducing symptoms of depression. The OHDC is offered over 13 weeks with 2-hour sessions in a clinical setting. The CWD, an evidence-based cognitive behavioral depression intervention. The CWD is offered over 8 weeks with 2-hour sessions in a clinical. Arms: lifestyle counseling (OHDC), lifestyle counseling (CWD)
Primary Outcome Measure Information:
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D scale is a 20-item self-report inventory developed by NIMH to assess the frequency and severity of depression symptoms in the past week. Respondents indicate how often each symptom was experienced during the past week on a four-point scale from "Rarely or none of the time (0)", "Some or a little of the time (1)", "Occasionally or a moderate amount of the time (2)", or "Most or all of the time (3)". Item scores are summed for analyses, with a possible range 0-60. A standard cutoff score of 16 indicates depressive symptoms.
Time Frame
up to 4 years
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology (QIDS)
Description
The 16-item Quick Inventory of Depressive Symptomatology (QIDS) using DSM-IV criteria assesses depressive symptom severity and symptom change. The QIDS has a clinician-rated and self-report format. Studies show high internal consistency for the QIDS-CR (0.85) and QIDS-SR(0.86). Scores range from 0-27 and higher scores suggest higher severity. The QIDS also has high concurrent validity with the SF-12.
Time Frame
up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria. Self-identified African-American men and women, between the ages of 30 to 60, with symptoms of depression as evidenced by data from the Composite International Diagnostic Interview 2.1 (CIDI). Although age of inclusion is broad, our pilot studies have shown positive outcomes with mixed aged groups Exclusion Criteria: Exclusion criteria. Individuals will be excluded from the study if they have: (1) self-reported alcohol or other drug abuse/dependence, (2) major psychotic illnesses, such as schizophrenia as evidenced by results of the CIDI, (3) self-reported changes in antidepressants (dosage or type) less than 6 weeks prior to participating in the study, (4) self-report of current psychotherapy treatment, or (5) self-report of current suicidal ideations (our psychiatrist will conduct additional suicide risk assessment and facilitate referral for appropriate care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Earlise C Ward, Ph.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Center of Dane County
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53703
Country
United States
Facility Name
Milwaukee Health Services, INC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53216
Country
United States

12. IPD Sharing Statement

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African American Depression Intervention Trial (AADI)

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